左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614233794230944230854232294235184232610.05
213.634215684217734216700.04
单位质量响应值RSD%判断
31099.2730936.900.38数据可信
供试品溶液-2024072121批-左氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1327763-32776374.13065.2220.6874.1365.2220.68
2247342-24734255.94155.94
3275782-27578262.37462.37
4334403-33440375.63275.63
5195799-19579944.28444.28
6349091-34909178.95478.95
10min1411950-41195093.17193.042.9793.3993.233.00
2394919-39491989.31989.49
3411953-41195393.17293.36
4427548-42754896.69996.93
5400651-40065190.61590.75
6421113-42111395.24395.48
15min1420149-42014995.02595.791.6295.5396.271.65
2420162-42016295.02895.46
3421536-42153695.33995.81
4434192-43419298.20198.72
5415829-41582994.04894.45
6429381-42938197.11397.64
20min1420701-42070195.15095.862.4095.9496.632.42
2421866-42186695.41496.13
3423059-42305995.68396.44
4440659-44065999.664100.48
5409519-40951992.62193.31
6427356-42735696.65597.47
30min1424649-42464996.04396.891.8097.1297.941.83
2427503-42750396.68997.70
3425484-42548496.23297.27
4441242-44124299.796100.91
5418882-41888294.73995.70
6432604-43260497.84298.95
45min1424601-42460196.03297.452.0897.3998.792.10
2430654-43065497.40198.70
3426845-42684596.54097.87
4446080-446080100.890102.30
5421460-42146095.32296.57
6435636-43563698.52899.93
60min1426679-42667996.50297.522.0598.1599.162.08
2430805-43080597.43599.02
3429699-42969997.18598.80
4445714-445714100.807102.52
5419271-41927194.82796.36
6434999-43499998.384100.08
极限1423714-42371495.83297.221.9897.7799.142.00
2429663-42966397.17799.06
3426314-42631496.42098.33
4445336-445336100.722102.74
5421817-42181795.40397.22
6432266-43226697.76699.75
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.068470418462268465528459478466778464890.05
210.078441628442468442040.01
单位质量响应值RSD%判断
84144.0483833.570.27数据可信
供试品溶液-2024072121批-贝那普利-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1205156-20515624.23114.9092.0524.2314.9092.05
2-0.0000.00
3299167-29916735.33535.34
456606-566066.6866.69
531269-312693.6933.69
6164773-16477319.46219.46
10min1822664-82266497.16695.563.4097.2495.603.42
2754970-75497089.17189.17
3814098-81409896.15496.26
4813461-81346196.07996.10
5816253-81625396.40996.42
6832796-83279698.36398.42
15min1834804-83480498.60098.081.0398.9698.411.04
2820408-82040896.90097.17
3824231-82423197.35197.75
4825964-82596497.55697.86
5833147-83314798.40498.70
6843708-84370899.652100.00
20min1831922-83192298.25997.810.8698.9298.440.86
2823832-82383297.30497.86
3819671-81967196.81297.50
4823363-82336397.24997.85
5831257-83125798.18198.78
6838818-83881899.07499.73
30min1828013-82801397.79897.570.7598.7598.490.75
2823597-82359797.27698.13
3819025-81902596.73697.71
4821302-82130297.00597.90
5828651-82865197.87398.76
6836080-83608098.75199.70
45min1826199-82619997.58497.340.8298.8398.550.81
2824316-82431697.36198.50
3814551-81455196.20897.47
4819116-81911696.74797.93
5826519-82651997.62198.80
6833999-83399998.50599.75
60min1824820-82482097.42197.020.7898.9698.520.77
2821534-82153497.03398.47
3812696-81269695.98997.54
4815792-81579296.35497.83
5823483-82348397.26398.74
6830185-83018598.05499.60
极限1820950-82095096.96496.640.8798.8098.440.86
2818752-81875296.70498.43
3807333-80733395.35597.20
4812820-81282096.00397.77
5822485-82248597.14598.91
6827091-82709197.68999.52
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614231924229344228834230724229414230040.03
213.634223284221044222160.04
单位质量响应值RSD%判断
31080.3830976.960.24数据可信
供试品溶液-2024072121批-左氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1305274-30527469.02058.8423.6669.0258.8423.67
2258715-25871558.49458.49
3357558-35755880.84180.84
4189677-18967742.88542.88
5226504-22650451.21151.21
6223672-22367250.57150.57
10min1408494-40849492.35793.262.4992.5693.432.52
2423617-42361795.77795.95
3425654-42565496.23796.48
4399185-39918590.25390.38
5411155-41115592.95993.11
6406773-40677391.96892.12
15min1420577-42057795.08995.691.8895.5796.151.91
2429928-42992897.20397.67
3433602-43360298.03498.57
4411423-41142393.02093.42
5424436-42443695.96296.39
6419525-41952594.85195.28
20min1427049-42704996.55396.591.6997.3297.331.72
2436399-43639998.66799.42
3434077-43407798.14298.97
4417045-41704594.29194.97
5426414-42641496.40997.13
6422236-42223695.46496.18
30min1427571-42757196.67197.001.7697.7398.041.79
2437606-43760698.93999.99
3436720-43672098.73999.86
4417378-41737894.36695.33
5429367-42936797.07798.09
6425551-42555196.21497.21
45min1427629-42762996.68497.381.8498.0398.701.87
2441471-44147199.813101.16
3439381-43938199.341100.76
4422052-42205295.42396.67
5428792-42879296.94798.25
6424877-42487796.06197.35
60min1428124-42812496.79697.362.1298.4398.982.14
2441258-44125899.765101.41
3440469-44046999.587101.30
4417610-41761094.41895.95
5431006-43100697.44799.04
6425252-42525296.14697.72
极限1428190-42819096.81197.741.5898.7499.641.61
2441572-44157299.836101.78
3439767-43976799.428101.44
4424785-42478596.04197.85
5430749-43074997.38999.27
6428677-42867796.92198.78
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.068474428467358469338474068465638470160.05
210.078455098447818451450.07
单位质量响应值RSD%判断
84196.4283927.010.23数据可信
供试品溶液-2024072121批-贝那普利-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1689892-68989281.41331.8289.3581.4131.8289.34
2124815-12481514.72914.73
3284731-28473133.60133.60
4-0.0000.00
5160565-16056518.94818.95
6357936-35793642.24042.24
10min1825125-82512597.37296.031.7097.6296.131.75
2816086-81608696.30596.35
3802122-80212294.65794.76
4792063-79206393.47093.47
5826668-82666897.55497.61
6820621-82062196.84196.97
15min1826105-82610597.48897.921.2898.0298.301.28
2835400-83540098.58598.92
3813414-81341495.99096.37
4823685-82368597.20297.48
5838874-83887498.99599.34
6841172-84117299.26699.68
20min1825173-82517397.37897.681.3198.2198.361.31
2835871-83587198.64099.27
3810070-81007095.59596.27
4821584-82158496.95497.53
5835898-83589898.64399.29
6837583-83758398.84299.56
30min1823113-82311397.13597.351.3198.2698.321.31
2832708-83270898.26799.19
3808369-80836995.39596.35
4816957-81695796.40897.27
5832843-83284398.28399.23
6835510-83551098.59899.61
45min1816790-81679096.38896.851.2097.8098.111.19
2828235-82823597.73998.96
3805941-80594195.10896.35
4814603-81460396.13097.28
5829790-82979097.92399.16
6828900-82890097.81899.12
60min1816788-81678896.38896.581.3298.0998.141.31
2828387-82838797.75799.27
3801745-80174594.61396.14
4810790-81079095.68097.12
5828375-82837597.75699.29
6824538-82453897.30398.90
极限1814780-81478096.15196.421.1798.1498.261.17
2821965-82196596.99998.81
3801020-80102094.52796.34
4813056-81305695.94897.68
5824993-82499397.35699.18
6826359-82635997.51899.41
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